2024
Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable
Yap C, Aiyegbusi O, Alger E, Basch E, Bell J, Bhatnagar V, Cella D, Collis P, Dueck A, Gilbert A, Gnanasakthy A, Greystoke A, Hansen A, Kamudoni P, Kholmanskikh O, King-Kallimanis B, Krumholz H, Minchom A, O'Connor D, Petrie J, Piccinin C, Rantell K, Rauz S, Retzer A, Rizk S, Wagner L, Sasseville M, Seymour L, Weber H, Wilson R, Calvert M, Peipert J. Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable. EClinicalMedicine 2024, 76: 102838. PMID: 39386161, PMCID: PMC11462221, DOI: 10.1016/j.eclinm.2024.102838.Peer-Reviewed Original ResearchEarly phase trialsPatient-reported outcomesPhase trialsInvestigator-reported adverse eventsEarly phase clinical trialsTolerability assessmentsPhase clinical trialsIntegration of patient-reported outcomesAdverse eventsClinical trialsPatient-centred careDosing decisionsDiverse clinical areasTherapy risksLaboratory assessmentPatientsTrialsPatient advocatesClinical areasOutcomesSafety alertsPharmaceutical representativesVirtual roundtableRisk
2022
Temporal trends in postoperative and ventilator-associated pneumonia in the United States
Metersky M, Wang Y, Klompas M, Eckenrode S, Mathew J, Krumholz H. Temporal trends in postoperative and ventilator-associated pneumonia in the United States. Infection Control And Hospital Epidemiology 2022, 44: 1247-1254. PMID: 36326283, DOI: 10.1017/ice.2022.264.Peer-Reviewed Original ResearchConceptsVentilator-associated pneumoniaMajor surgical proceduresPostoperative pneumoniaAcute myocardial infarctionSurgical proceduresHeart failureMyocardial infarctionMedicare Patient Safety Monitoring SystemAnnual riskRetrospective cohort studyPrior yearRisk-adjusted ratesAdverse event measuresCohort studyRetrospective reviewPneumoniaPatientsInfarctionUnited StatesRiskSignificant changesYearsTemporal trendsFailure
2021
Obesity Prevalence and Risks Among Chinese Adults
Mu L, Liu J, Zhou G, Wu C, Chen B, Lu Y, Lu J, Yan X, Zhu Z, Nasir K, Spatz ES, Krumholz HM, Zheng X. Obesity Prevalence and Risks Among Chinese Adults. Circulation Cardiovascular Quality And Outcomes 2021, 14: e007292. PMID: 34107739, PMCID: PMC8204767, DOI: 10.1161/circoutcomes.120.007292.Peer-Reviewed Original ResearchConceptsAbdominal obesitySocio-demographic subgroupsSocio-demographic associationsOverall obesityHigh riskMillion Persons ProjectEpidemic of obesityAge-standardized ratesCommunity-dwelling adultsAssociation of ageMultivariable mixed modelsObesity prevalenceOlder womenLower riskObesityOlder menChinese adultsPrevalenceWomenRiskMenPersons ProjectSubgroupsAssociationAdults
2020
Associations Between the Severity of Influenza Seasons and Mortality and Readmission Risks After Elective Surgical Aortic Valve Replacement and Coronary Artery Bypass Graft Surgery in Older Adults
Mori M, Wang Y, Mahajan S, Geirsson A, Krumholz HM. Associations Between the Severity of Influenza Seasons and Mortality and Readmission Risks After Elective Surgical Aortic Valve Replacement and Coronary Artery Bypass Graft Surgery in Older Adults. JAMA Network Open 2020, 3: e2031078. PMID: 33355673, PMCID: PMC7758803, DOI: 10.1001/jamanetworkopen.2020.31078.Peer-Reviewed Original ResearchConceptsSurgical aortic valve replacementElective surgical aortic valve replacementAortic valve replacementValve replacementReadmission riskCoronary artery bypass graft surgeryArtery bypass graft surgeryOlder adultsBypass graft surgeryCoronary artery bypassCross-sectional studyArtery bypassGraft surgeryInfluenza seasonMedicaid ServicesMortalitySeverityAdultsRiskAssociationSurgeryBypass
2019
Noninferiority Designed Cardiovascular Trials in Highest-Impact Journals
Bikdeli B, Welsh JW, Akram Y, Punnanithinont N, Lee I, Desai NR, Kaul S, Stone G, Ross JS, Krumholz HM. Noninferiority Designed Cardiovascular Trials in Highest-Impact Journals. Circulation 2019, 140: 379-389. PMID: 31177811, PMCID: PMC8416048, DOI: 10.1161/circulationaha.119.040214.Peer-Reviewed Original ResearchConceptsNoninferiority marginNoninferiority trialCardiovascular trialsAllocation concealmentLower riskOpen labelHazard ratioRelative riskMethodological qualityProportion of trialsIndependent reviewersRisk differenceNew England JournalNoninferiorityHigh-impact journalsNew interventionsTrialsCohortDiscrepant resultsProtocol analysisTime trendsRiskTreatInterventionFactorsDo pregnant women living in higher well-being populations in the USA experience lower risk of preterm delivery? A cross-sectional study
Riley C, Roy B, Herrin J, Spatz E, Silvestri MT, Arora A, Kell KP, Rula EY, Krumholz HM. Do pregnant women living in higher well-being populations in the USA experience lower risk of preterm delivery? A cross-sectional study. BMJ Open 2019, 9: e024143. PMID: 31048427, PMCID: PMC6501974, DOI: 10.1136/bmjopen-2018-024143.Peer-Reviewed Original ResearchConceptsPreterm birthCross-sectional studyIndividual risk factorsPreterm deliveryRisk factorsPregnant womenLower riskMaternal risk factorsPrimary outcome measurePrimary independent variableGestational ageMaternal riskOutcome measuresUS birthsHealth StatisticsBirth dataBeing IndexWomenBirthGallup-Sharecare WellLower ratesQuintileRiskDeliveryPopulation
2018
Accurate estimation of cardiovascular risk in a non-diabetic adult: detecting and correcting the error in the reported Framingham Risk Score for the Systolic Blood Pressure Intervention Trial population
Warner F, Dhruva SS, Ross JS, Dey P, Murugiah K, Krumholz HM. Accurate estimation of cardiovascular risk in a non-diabetic adult: detecting and correcting the error in the reported Framingham Risk Score for the Systolic Blood Pressure Intervention Trial population. BMJ Open 2018, 8: e021685. PMID: 30037874, PMCID: PMC6059296, DOI: 10.1136/bmjopen-2018-021685.Peer-Reviewed Original ResearchConceptsSystolic Blood Pressure Intervention TrialFramingham risk scoreCardiovascular riskRisk scoreStudy populationStudy participantsNon-diabetic adultsTotal study populationHigh-risk populationClinical trial dataClinical trial sitesTrial populationIntervention trialsRisk populationsNew England JournalIndependent investigatorsTrial dataSecondary analysisSPRINT trialSPRINT dataTrialsRiskScoresParticipantsPopulation
2017
Trends in acute pericarditis hospitalizations and outcomes among the elderly in the USA, 1999–2012
Mody P, Bikdeli B, Wang Y, Imazio M, Krumholz HM. Trends in acute pericarditis hospitalizations and outcomes among the elderly in the USA, 1999–2012. European Heart Journal - Quality Of Care And Clinical Outcomes 2017, 4: 98-105. PMID: 29106473, PMCID: PMC6279101, DOI: 10.1093/ehjqcco/qcx040.Peer-Reviewed Original ResearchConceptsLength of stayHospitalization ratesMortality rateReadmission ratesStudy periodCause readmission rateCause mortality ratesLong-term outcomesPrincipal discharge diagnosisRisk of pericarditisHealth care expendituresAcute pericarditisCardiac surgeryRenal diseaseDischarge diagnosisPericarditisHigh riskMedicare beneficiariesHospitalizationOlder adultsCare expendituresStayOutcomesRiskCause
2014
Approaches to Enhancing Radiation Safety in Cardiovascular Imaging
Fazel R, Gerber TC, Balter S, Brenner DJ, Carr JJ, Cerqueira MD, Chen J, Einstein AJ, Krumholz HM, Mahesh M, McCollough CH, Min JK, Morin RL, Nallamothu BK, Nasir K, Redberg RF, Shaw LJ. Approaches to Enhancing Radiation Safety in Cardiovascular Imaging. Circulation 2014, 130: 1730-1748. PMID: 25366837, DOI: 10.1161/cir.0000000000000048.Peer-Reviewed Original Research
2013
Post-Hospital Syndrome — An Acquired, Transient Condition of Generalized Risk
Krumholz HM. Post-Hospital Syndrome — An Acquired, Transient Condition of Generalized Risk. New England Journal Of Medicine 2013, 368: 100-102. PMID: 23301730, PMCID: PMC3688067, DOI: 10.1056/nejmp1212324.Peer-Reviewed Original Research
2012
Loneliness and Living Alone: Comment on “Loneliness in Older Persons” and “Living Alone and Cardiovascular Risk in Outpatients at Risk of or With Atherothrombosis”
Bucholz EM, Krumholz HM. Loneliness and Living Alone: Comment on “Loneliness in Older Persons” and “Living Alone and Cardiovascular Risk in Outpatients at Risk of or With Atherothrombosis”. JAMA Internal Medicine 2012, 172: 1084-1085. PMID: 22710997, PMCID: PMC3670596, DOI: 10.1001/archinternmed.2012.2649.Peer-Reviewed Original Research
2009
Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance
Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM. Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance. JAMA Internal Medicine 2009, 169: 1976-1985. PMID: 19933959, PMCID: PMC2830805, DOI: 10.1001/archinternmed.2009.394.Peer-Reviewed Original ResearchMeSH KeywordsAdverse Drug Reaction Reporting SystemsCardiovascular SystemCyclooxygenase 2 InhibitorsDrug IndustryHumansIncidenceLactonesMyocardial InfarctionRandomized Controlled Trials as TopicRisk AssessmentSafety-Based Drug WithdrawalsSulfonesTime FactorsUnited StatesUnited States Food and Drug AdministrationConceptsPlacebo-controlled trialVoluntary market withdrawalAdverse eventsCardiovascular riskThromboembolic adverse eventsMain outcome measurementsClinical trial dataRofecoxib groupOutcome measurementsTrial dataPlaceboTrial durationSafety surveillanceTrialsMarket withdrawalDeathRiskP-valueSurveillance effortsSubjectsWithdrawalRofecoxibYearsIncidenceDosePredictors of Venous Thromboembolism in Patients with Advanced Common Solid Cancers
Hall IE, Andersen MS, Krumholz HM, Gross CP. Predictors of Venous Thromboembolism in Patients with Advanced Common Solid Cancers. Journal Of Cancer Epidemiology 2009, 2009: 182521. PMID: 20445797, PMCID: PMC2859683, DOI: 10.1155/2009/182521.Peer-Reviewed Original ResearchVenous thromboembolismVTE riskOlder patientsAdvanced cancerEnd Results cancer registryRetrospective cohort studyVTE ratesCohort studyCancer RegistrySurvival analysisPatientsCancer diagnosisCancerFirst yearRisk heterogeneityRiskThromboembolismComorbiditiesRegistryLungColonProstatePancreasBreastEpidemiology
2007
Renal Impairment Predicts Long-Term Mortality Risk after Acute Myocardial Infarction
Smith GL, Masoudi FA, Shlipak MG, Krumholz HM, Parikh CR. Renal Impairment Predicts Long-Term Mortality Risk after Acute Myocardial Infarction. Journal Of The American Society Of Nephrology 2007, 19: 141-150. PMID: 18003773, PMCID: PMC2391037, DOI: 10.1681/asn.2007050554.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionRenal functionRenal impairmentCreatinine clearanceMortality riskMyocardial infarctionCockcroft-Gault creatinine clearanceLong-term mortality riskMild renal impairmentSevere renal impairmentNormal renal functionCohort of patientsCooperative Cardiovascular ProjectPatient ageSystolic functionHospitalized patientsPrognostic importanceRisk factorsPatientsMortalityImpairmentClearanceGFRInfarctionRisk
2006
Renal Impairment and Outcomes in Heart Failure Systematic Review and Meta-Analysis
Smith GL, Lichtman JH, Bracken MB, Shlipak MG, Phillips CO, DiCapua P, Krumholz HM. Renal Impairment and Outcomes in Heart Failure Systematic Review and Meta-Analysis. Journal Of The American College Of Cardiology 2006, 47: 1987-1996. PMID: 16697315, DOI: 10.1016/j.jacc.2005.11.084.Peer-Reviewed Original ResearchConceptsRenal impairmentHF patientsSevere impairmentRenal functionExcess mortalityMortality riskSystematic reviewAssociated mortality riskHeart failure patientsCause mortality riskPrecise risk estimatesCause mortalityFailure patientsDL increaseRisk stratificationTherapeutic strategiesPatientsMeta-AnalysisMortalityRisk estimatesImpairmentSystematic searchMin decreaseRiskCreatinine
2005
Prior Aspirin Use and Outcomes in Elderly Patients Hospitalized With Acute Myocardial Infarction
Portnay EL, Foody JM, Rathore SS, Wang Y, Masoudi FA, Curtis JP, Krumholz HM. Prior Aspirin Use and Outcomes in Elderly Patients Hospitalized With Acute Myocardial Infarction. Journal Of The American College Of Cardiology 2005, 46: 967-974. PMID: 16168277, PMCID: PMC2790536, DOI: 10.1016/j.jacc.2005.06.049.Peer-Reviewed Original ResearchConceptsPrior aspirin useCondition-specific readmissionAspirin useMyocardial infarctionCause readmissionMedicare beneficiariesSix-month mortalityAcute myocardial infarctionElderly patientsMultivariable adjustmentPrognostic significanceHigh riskReadmissionLower riskLower mortalityPatientsOne monthMortalityMonthsInfarctionOne-thirdNational sampleRiskMarkersAssociationDiagnosis, Evaluation, and Treatment of Childhood Obesity in Pediatric Practice
Dorsey KB, Wells C, Krumholz HM, Concato J. Diagnosis, Evaluation, and Treatment of Childhood Obesity in Pediatric Practice. JAMA Pediatrics 2005, 159: 632-638. PMID: 15996996, DOI: 10.1001/archpedi.159.7.632.Peer-Reviewed Original ResearchConceptsBody mass indexRisk of overweightHospital-based clinicsHealth maintenance visitsRate of diagnosisType of treatmentComorbid diseasesMass indexOverweight childrenChildhood obesityMedical recordsTreatment recommendationsHigh burdenPediatric practiceRoutine screeningOverweightClinical practiceMaintenance visitsDiagnosisEncounter notesFormal diagnosisTreatmentChildrenSingle-parent householdsRisk
2003
Are Statins Indicated for the Primary Prevention of CAD in Octogenarians? Angagonist Viewpoint
Foody JM, Krumholz HM. Are Statins Indicated for the Primary Prevention of CAD in Octogenarians? Angagonist Viewpoint. The American Journal Of Geriatric Cardiology 2003, 12: 357-360. PMID: 14610384, DOI: 10.1111/j.1076-7460.2003.02912.x.Peer-Reviewed Original ResearchConceptsCoronary artery diseasePrimary preventionArtery diseaseOvert coronary artery diseaseRisk of myositisCardiovascular disease eventsRole of statinsUse of statinsAge 65 yearsBalance of risksCardiovascular eventsStatin therapyPatient preferencesCholesterol levelsCardiovascular diseaseOctogenariansClinical uncertaintyDisease eventsCurrent evidenceStatinsAge groupsDiseasePreventionRiskMyositisWorsening renal function: What is a clinically meaningful change in creatinine during hospitalization with heart failure?
Smith GL, Vaccarino V, Kosiborod M, Lichtman JH, Cheng S, Watnick SG, Krumholz HM. Worsening renal function: What is a clinically meaningful change in creatinine during hospitalization with heart failure? Journal Of Cardiac Failure 2003, 9: 13-25. PMID: 12612868, DOI: 10.1054/jcaf.2003.3.Peer-Reviewed Original ResearchMeSH KeywordsAgedBiomarkersCohort StudiesConnecticutCreatinineFemaleFollow-Up StudiesHeart FailureHospitalizationHumansKidney DiseasesKidney Function TestsMaleMiddle AgedMultivariate AnalysisPredictive Value of TestsProspective StudiesRisk FactorsSensitivity and SpecificityStatistics as TopicStroke VolumeSurvival AnalysisConceptsCreatinine elevationRenal functionHeart failureAdverse outcomesRisk of deathNumber of patientsMagnitude of riskBaseline creatinineProspective cohortRisk factorsFunctional declineHigh riskPatientsCreatinineMortalityHospitalizationDeathDlImportant predictorRiskElevationMeaningful changeMaximum specificityOutcomesBetter definition
2002
Cardiac outcomes after myocardial infarction in elderly patients with diabetes mellitus.
Chyun D, Vaccarino V, Murillo J, Young LH, Krumholz HM. Cardiac outcomes after myocardial infarction in elderly patients with diabetes mellitus. American Journal Of Critical Care 2002, 11: 504-19. PMID: 12425401, DOI: 10.4037/ajcc2002.11.6.504.Peer-Reviewed Original ResearchConceptsRecurrent myocardial infarctionInsulin-treated diabetes mellitusDiabetes mellitusMyocardial infarctionElderly patientsHeart failureVentricular functionComorbid conditionsClinical findingsIndex myocardial infarctionPoor ventricular functionInsulin-treated diabetesAcute myocardial infarctionCardiac outcomesPoor outcomeMedical recordsMellitusInfarctionMedicare beneficiariesPatientsGreater riskInsulinMortalityRiskOutcomes